Biologics Manufacturing Specialist
3 days ago
Job Overview
At Replimune, Inc., we are seeking a skilled Biologics Manufacturing Specialist to join our team. As a key member of our manufacturing operations, you will be responsible for providing technical support for oncolytic virus manufacturing, including life cycle management of commercial processes.
Estimated Salary: $120,000 - $180,000 per year (depending on location and experience)
About the Role
As a Biologics Manufacturing Specialist, you will work closely with cross-functional teams to troubleshoot issues with drug substance and/or drug product processing technologies and equipment. You will provide effective life cycle management through CAPA/Change Control execution and deviation resolution, and drive continuous improvement in our cGMP process steps.
Key Responsibilities
- Support oncolytic virus drug substance and/or drug product manufacturing process technology transfer and post-transfer manufacturing support.
- Provide technical expertise in troubleshooting issues with drug substance and/or drug product processing technologies and equipment.
- Provide effective life cycle management through CAPA/Change Control execution and deviation resolution.
- Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through change requests or technology builds for commercial processes.
- Monitor commercial process performance and perform evaluation of continuous process verification data and trends.
Requirements
To be successful in this role, you will need a Master's degree in chemical or biomedical engineering or equivalent and 0-3 years of related work experience, or a Bachelor's degree in chemical or biomedical engineering or equivalent and 2-5 years of related work experience.
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